US FDA expected to authorise emergency use of remdesivir

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The US National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health, has announced positive results from its study of Gilead's antiviral remdesivir.

The agency said hospitalised patients with advanced COVID-19 and lung involvement who received remdesivir recovered faster than similar patients who received placebo.

The study involving 1,063 patients began in late February as the pandemic emerged. 

Preliminary results found patients who received remdesivir had a 31 per cent faster time to recovery than those who received placebo. The median time to recovery was 11 days for patients treated with remdesivir compared with 15 days for those who received placebo.

It reported a mortality rate of 8 per cent for the group receiving remdesivir compared to 11.6 per cent for the placebo group.

The New York Times reported the FDA could authorise the emergency use of remdesivir this week.

Johnson & Johnson, which is one of several companies working on the development of a potential COVID-19 vaccine, also announced another agreement to increase its manufacturing capacity ahead of any approval.

The company said it had secured an agreement with Catalent to increase capacity at one of its US-based facilities. the agreement will see Catalent recruit an additional 300 employees at the facility with the goal of reaching 24/7 manufacturing schedules by January 2021.

Johnson & Johnson recently announced a similar deal with Emergent BioSolutions.